510(k) K200436 ยท QEP Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test kit, Aptima Trichomonas Vaginalis (Panther) - 250 test kit, Aptima Trichomonas Vaginalis (Tigris) - 250 test kit
| Applicant | Hologic, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Mar 23, 2020 |
| Received | Feb 24, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K200436
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.